Table 1. Characteristics of Patients at Baseline in the ARCADIA Triala.
| Characteristic | Group, No. (%) | |
|---|---|---|
| Apixaban (n = 507) | Aspirin (n = 508) | |
| Age, mean (SD), y | 67.8 (10.8) | 68.2 (11.0) |
| Sex | ||
| Female | 272 (53.7) | 279 (54.9) |
| Male | 235 (46.3) | 229 (45.1) |
| Raceb | n = 501 | n = 500 |
| Asian | 7 (1.4) | 10 (2.0) |
| Black or African American | 107 (21.4) | 107 (21.4) |
| White | 381 (76.0) | 379 (75.8) |
| Other | 6 (1.2) | 4 (0.8) |
| Ethnicityb | n = 505 | n = 505 |
| Hispanic or Latino | 43 (8.5) | 39 (7.7) |
| Not Hispanic or Latino | 462 (91.5) | 466 (92.3) |
| Weight, mean (SD), kg | 85.1 (20.1) | 84.5 (20.2) [n = 506] |
| Documented medical comorbiditiesc | ||
| Hypertension | 396 (78.1) | 388 (76.4) |
| Prior or current tobacco use | 230 (45.4) | 200 (39.4) |
| Diabetes | 156 (30.8) | 159 (31.3) |
| Prior stroke or TIA | 97 (19.1) | 100 (19.7) |
| Ischemic heart disease | 58 (11.4) | 46 (9.1) |
| Heart failure | 36 (7.1) | 35 (6.9) |
| Peripheral arterial disease | 12 (2.4) | 7 (1.4) |
| CHA2DS2-VASc score, mean (SD)d | 4.7 (1.3) | 4.7 (1.3) |
| NIH Stroke Scale score, median (IQR)e | 1 (0-3) [n = 504] | 1 (0-3) [n = 506] |
| Atrial cardiopathy biomarkers | ||
| NT-proBNP, median (IQR), pg/mL | 288 (87-535) [n = 502] | 318 (130-551) [n = 496] |
| PTFV1, mean (SD), μV × ms | 4716 (2515) [n = 501] | 4766 (2920) [n = 503] |
| LA diameter index, mean (SD), cm/m2 | 1.9 (0.5) [n = 406] | 1.9 (0.5) [n = 412] |
| Days from index stroke to randomization, median (IQR) | 48 (21-96) | 53 (23-100) |
Abbreviations: ARCADIA, Atrial Cardiopathy and Antithrombotic Drugs in Prevention After Cryptogenic Stroke; CHA2DS2-VASc, congestive heart failure, hypertension, age ≥75 years (doubled), diabetes, stroke/transient ischemic attack/thromboembolism (doubled), vascular disease (prior myocardial infarction, peripheral artery disease, or aortic plaque), age 65-75 years, sex category (female); LA, left atrial; NIH, National Institutes of Health; NT-proBNP, N-terminal pro-B-type natriuretic peptide; PTFV1, P-wave terminal force in lead V1; TIA, transient ischemic attack.
Percentages may not total 100 because of rounding.
Other race was defined as Alaska Native or American Indian, Native Hawaiian or Other Pacific Islander, or more than 1. Site investigators and coordinators were instructed to ask participants to report self-identified race and ethnicity, which were then categorized per NIH guidelines.
Determined by site investigators and coordinators based on the medical record and patient self-report.
This score assigns 2 points each for age 75 years or older, prior stroke, or transient ischemic attack and 1 point each for hypertension, diabetes, peripheral vascular disease, age 65 to 74 years, or female sex. This score has been shown to have moderate predictive value for thromboembolism in atrial fibrillation. The score ranges from 0-9 and higher scores indicate a higher risk of thromboembolism.
The NIH Stroke Scale, a standardized neurologic examination used to quantify the degree of functional deficit resulting from a stroke, ranges from 0-42, with higher scores indicating a greater degree of neurologic impairment.